evaluate the efficacy and safety of rasburicase (fasturtec®) in the prevention and treatment of hyperuricemia in pediatric patients with non-hodgkin's lymphoma and acute leukemia

Conditions: Lymphoma

Summary: primary objective: to evaluate safety of rasburicase in pediatric patients with nhl and al secondary objective: to assess efficacy of rasburicase for prevention and treatment of hyperuricemia

study duration per participants is approximatively 14 days including a 5-day treatment period.

Eligibility criteria:
inclusion criteria : * patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent. * children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent. * at screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (ps) no greater than 3 on the eastern cooperative oncology group (ecog) scale, or a ps no less than 30 on the lansky score as per the investigator's preference (see appendix d for ecog and lansky scale). * newly diagnosed nhl or al who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg/dl (473 mol/l) at screening. * if newly diagnosed nhl patient with blood uric acid no greater than 8 mg/dl at screening, the patient must be diagnosed with stage iii or iv non-hodgkin's lymphoma with high tumor burden which will be high risk of tls defined, with one or more of following below: a. burkitt lymphoma/leukemia or -lymphoblastic lymphoma, and/or b. has at least one of lymph node or tumor, the diameter \>5 cm, and/or c. lactate dehydrogenase (ldh) no less than 2 times the upper limit of normal (uln). * if newly diagnosed al patient is with blood uric acid no greater than 8 mg/dl at the screening but with a high risk of tls defined with one of the following below criteria: a. white blood cell (wbc) no less than 100.0 10-9/l, or b. wbc \< 100.0 10-9/l with ldh no less than 2 uln. * the patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase. exclusion criteria: * acute promyelocytic leukemia * patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration. * patients with abnormal liver or renal function: alanine aminotransferase (alt) \>5 uln, total bilirubin \>3 uln, serum creatinine \>3 uln. * documented history of hereditary allergy or asthma. * patients with known deficiency of glucose-6-phosphate dehydrogenase (g6pd), or a history of hemolytic disease or methemoglobinemia. * patients with severe infection or active bleeding. * previous therapy with urate oxidase. * hypersensitive reaction against rasburicase or any of the other ingredients of the study drug. * patient is not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. * pregnant or breastfeeding woman. * woman of childbearing potential (wocbp) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in appendix a). * male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.